Medical device certification to streamline quality
The update to ISO 13485:2003, the internationally recognized quality management systems standard for the medical device industry, with over 27,000 certificates globally, was published on February 25, 2016. For more information about the changes, see our ISO 13485:2016 fact sheet (.PDF).
The medical device business is grounded in trust. Before a device is used on a patient, it must first win the trust of many stakeholders. From medical staff, hospitals, and healthcare institutions to regulators and often the public themselves.
A quality management system is integral to this chain of trust. It ensures that your medical products consistently meet customer expectations of quality, safety, and performance.
Achieving ISO 13485 certification proves that your medical devices have been manufactured under a certified quality management system. Our auditors have an established history of assessing leading medical device manufacturers with ISO 13485 audits and certification. We know how to assess your operational efficiency.
Fulfill the requirements of ISO 13485:2016 with expert guidance
Discover the similarities and differences between the two standards
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